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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

EMA and FDA Set Up New Working Group on Rare Diseases

Posted 26 September 2016 | By Zachary Brennan

The new collaboration between the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) announced Monday will improve the sharing of information on various aspects of the development and scientific evaluation of medicines for rare diseases.

According to EMA, rare diseases affect 30 million people in the EU and approximately the same number in the US, though each disease individually concerns a limited number of patients. And since only a limited number of studies can be conducted for such small populations, both regulators are calling for more global collaboration.

the design of clinical trials in small populations and the use of statistical analysis methods

the selection and validation of trial endpoints

preclinical evidence to support development programs

opportunities for regulatory flexibility (approval supported by other than two adequate and well-controlled studies and/or use of a novel endpoint)

the design of post-marketing studies, in particular in the context of early access mechanisms such as EMA’s conditional marketing authorisation and FDA’s accelerated approval or breakthrough designation

Both regulators will allow for the confidential exchange of draft documents, policies under development and the discussion of more detailed information supporting the scientific basis for decision making.

The first meeting of the rare diseases cluster took place by teleconference on 23 September and future teleconferences will occur monthly, subject to need and predefined in advance, for approximately one hour and 30 minutes.

EMA also clarified that the existing EMA/FDA “cluster on orphan medicinal products” will continue to focus on information sharing and collaboration on orphan designation and exclusivity, as well as the agencies’ mechanisms to encourage the development of medicines for rare diseases.